Bristol-Meyer Squibb can donate to the Disaster Relief in Haiti, But can’t donate to the citizens in the United States that need it the most, the Melanoma Cancer Patients that are fighting for survival and don’t qualify for BMS’s Trials. These are the cancer patients that are falling through the Healthcare system cracks. Jumping on the band wagon to get some extra PR is not the way to try to bolster their image. I believe in helping Haiti, but also Charity should start at home. Are they doing to for Humanitarian reasons or is it a just a big brand recognition scheme? I believe it is for the PR.
What really happened with the Compassionate Drug care use for Melanoma Patients? They said as of 9-12-2008 that they had to stop the use because they were having trouble manufacturing it. I believe it was all a cover up. As of 9-12-2008 they have opened quite a few new Clinical Trials with Ipilimumab. Then they pointed to a new process. There is one problem I see here. It only takes 3 months to grow the antibodies. They already had the master seed vials from Medarex. It is a Batch fermentation process or a continuous feed process. At the most it should take 4 to 5 months with testing and Good GMP.
So about 18 months have elapsed since the stoppage and we still have no Compassionate Drug use. That means at least 3 to 4 batches were made. We confirmed at least one or two batches based on information from some Melanoma non-profit organizations.
Bristol-Meyer Squibb, Show Us the Patients, the Master Production Batch Record (MPBR) or Production Batch Record (PBR) for Ipilimumab
Bristol-Meyer Squibb, If there was truly a Shortage/problem in the production of Ipilimumab, the it would show up in the Master Production Batch Record (MPBR) or Production Batch Record (PBR).
They won’t respond because there was not incident. The reason they shut it down in my opinion was, they were loosing money giving it away. It was not in the plan “Sting of Pearls”, and since it was going to take longer to get it FDA approved, they wanted to stop the outflow of revenue.
As of 1-29-2010, I am still getting lip service from Bristol Meyer Squibb.
“In light of the previous demand, Bristol-Myers Squibb is committed to ensuring that a continuous supply of ipilimumab is available prior to the re-opening of compassionate use so there are no treatment interruptions for patients who initiate therapy. As you probably know, the manufacturing cycle time and testing of a biologic such as ipilimumab is more complex than what is traditionally seen with small-molecule synthetic chemical pills. For example, host cells need to be grown, the purification process requires several steps before the active pharmaceutical ingredient can be formulated and the complexities associated with the manufacturing process limit the amount of drug supply that can be produced at one time. For more information on the manufacturing of biologics, please visit the Biotechnology Industry Organization's website at: http://www.bio.org/healthcare/pmp/factsheet1.asp.
It doesn’t take a year and half to produce. It all comes down to power and Greed
It is taking way to long for this drug to come to market. It was discovered over 10 years ago by Dr. Jim Allison at USC.
Bristol Meyer Squibb Has not even filed for a BLA yet. Biological License Application
So we could be another year or two before they go infront of the FDA. Many Melanoma Patients will die in the meantime. It will be blood on the the Hands of Bristol-Meyer Squibb. Greed has over taken compassion.
Just look at the graphic they put up at one of their financial meeting. They know what they have.
They realize what they are holding in their Drug Pipeline.